Pivotal Study of the Intravenous Blood Glucose (IVBG) System, In-Clinic Setting

NCT00925080 | Completed

• 1 other identifier: PTL-900193, Rev01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate safety and accuracy of the IVBG System (the "System") when used to track blood glucose in insulin treated subjects with diabetes mellitus in an in-clinic setting for up to 72 hours (per subject). Reference blood glucose measurements will be collected across the entire reportable range of the System (e.g., 40 400 mg/dL) with adequate sampling at the upper and lower ends of this range. IVBG System accuracy will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI glucose levels \< 75 mg/dL, and within ±20% at YSI glucose levels \>75 mg/dL).

Conditions

Diabetes; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• IVBG System accuracy will primarily be assessed relative to ISO 15197 criteria (i.e., within ±15 mg/dL at YSI glucose levels < 75 mg/dL, and within ±20% at YSI glucose levels >75 mg/dL).

  72-hours

Study Arms (1)

A

Device: IVBG

Interventions

IVBG DEVICE

Venous blood glucose measurement every 7.5 minutes for 72-hours

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with insulin-requiring diabetes mellitus

You may qualify if:

• Age 18 years or older;
• Willing to participate in one 72-hour in-clinic session during which up to 72 venous blood samples drawn for YSI measurement of glucose concentration (maximum sampling frequency of 4 per hour), a fingerstick blood glucose measurement will also be performed at the time of each YSI blood draw;
• If instructed, be willing not to perform any activities that would result in submersion of the Sensor/Potentiostat in water or willing to wear a waterproof covering when submerging the Sensor/Potentiostat;
• Have been diagnosed with insulin-requiring diabetes mellitus and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
• Able to speak, read, and write English.

You may not qualify if:

• Have skin conditions or existing (or planned) medical instrumentation and/or dressings that preclude wearing the IVBG Sensor (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, or surgical dressings at the proposed wear site);
• Are pregnant (as demonstrated by a positive pregnancy test within 72-hours of device insertion);
• Have a contraindication to placement of a dedicated peripheral IV line;
• Have a known history of heparin-induced thrombocytopenia;
• Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
• Have any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).

Sponsors & Collaborators

• DexCom, Inc.: lead

Study Sites (3)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

Advanced Metabolic Care + Research

Escondido, California, 92026, United States

Location

Diabetes and Glandular Disease Research Associates, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: February 3, 2010

Record last verified: 2010-02

Locations

US (3)